We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Prof
Christine
Roffe
+44 (0)7740 372852
ms-maps-2@exmail.nottingham.ac.uk
Prof
Christine
Roffe
+44 (0)7740 372852
christine.roffe@uhnm.nhs.uk
More information about this study, what is involved and how to take part can be found on the study website.
Prevention of pneumonia caused by dysphagia after an acute stroke
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Stroke is the fourth most common cause of death in the UK. Despite great progress over the last 20 years, the only treatments shown to reduce the death rate are admission to a specialist stroke unit, prevention of blood clots by intermittent pneumatic leg compression, and surgery for brain swelling. Pneumonia is the most common cause of death after stroke and, even if not fatal, weakens the patient and delays recovery. Patients with a stroke often lose the ability to swallow safely. This can lead to food and drink spilling into the lungs. Stroke patients with swallowing problems are therefore at high risk of pneumonia.
When stroke patients are turned in bed, moved, or even when just resting in bed, they often vomit and inhale the contents of the mouth and/or stomach into the lungs. This is the most common cause of pneumonia after stroke. In a small pilot study conducted in a single hospital the researchers were able to show that metoclopramide, an anti-sickness drug, prevents pneumonia in patients with severe stroke when given regularly in the first 2 weeks. The aim of this study is to confirm this finding in a wider range of hospitals and to establish whether this can also reduce the number of patients who die from stroke.
This study will test whether metoclopramide, given early after stroke onset and continued for 2 weeks, is better than sham control (dummy treatment) for preventing pneumonia and death after stroke.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
Current inclusion criteria as of 04/04/2024:
1. Adults (18 years and over) with a clinical diagnosis of acute stroke (WHO definition excluding duration)
2. Within 24 hours of symptom onset (in wake-up stroke the onset is defined as the time the patient awoke or was found unless this is more than 12 h from last known well)
3. One of the two below criteria:
3a. Moderate to severe neurological impairment (NIH Stroke Scale/Score (NIHSS) ≥10) OR
3b. Dysphagia and NIHSS ≥6, unable to take normal unmodified oral diet or fluids because:
i) Too drowsy to be assessed formally or
ii) Failed bedside assessmen
You may not be able to take part if:
1. Definite or probable pneumonia (abnormal chest X-ray suggestive of pneumonia or focal chest signs with fever ≥38°C, or receiving antibiotic treatment at time of presentation)2. Contraindications to metoclopramide (hypersensitivity to metoclopramide, epilepsy, gastrointestinal obstruction, perforation, or haemorrhage, gastrointestinal surgery within the last week, Parkinson’s disease, treatment with levodopa or dopaminergic agonists, phaeochromocytoma or neuroleptic malignant syndrome or tardive dyskinesia or methaemoglobinaemia or NADH cytochrome –b5 deficiency)3. Clinical indication for regular antiemetic treatment 4. Known cirrhosis of the liver5. Known severe renal dysfunction (eGFR <30 ml/hour) 6. Pregnant or breastfeeding 7. Moribund (expected to die within the next 48 hours)8. Co-morbid conditions with life expectancy <3 months 9. Inability to gain consent (patient or legal representative) or consent declined
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Prof
Christine
Roffe
+44 (0)7740 372852
christine.roffe@uhnm.nhs.uk
Prof
Christine
Roffe
+44 (0)7740 372852
ms-maps-2@exmail.nottingham.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by University of Nottingham and funded by National Institute for Health Research.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 50728
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
